TY - JOUR
T1 - Informed consent for a neonatal clinical trial
T2 - parental experiences and perspectives
AU - Penut Neonatal Informed Consent Working Group
AU - Shah, Anita R.
AU - Wilfond, Benjamin S.
AU - Silvia, Amy
AU - Hancuch, Kerry
AU - Woodrum, David
AU - Heagerty, Patrick
AU - Ohls, Robin K.
AU - Courtney, Sherry E.
AU - Frantz, Ivan D.
AU - Gogcu, Semsa
AU - Bishop, Christine E.
AU - Ahmad, Kaashif A.
AU - Kathen, Charmaine
AU - Juul, Sandra
AU - Arzuaga, Bonnie
AU - Baker, Catherine L.
AU - Beauman, Sandra
AU - Brown, Tiffany
AU - Daly, Rita
AU - Drummond, Melanie
AU - Dweck, Natalie
AU - Franco, Ariana
AU - Giblin, Clare
AU - Hedrick, Pamela
AU - Kase, Jordan
AU - Khan, Janine
AU - Lanier, Kristi
AU - Mason, Melanie
AU - McConnell, Jana
AU - Ott, Deborah
AU - Patel, Palak
AU - Robinson, Patricia
AU - Schau, Molly
AU - Vijayamadhavan, Vivek
AU - Ziyeh, Tiglath
N1 - Funding Information:
Acknowledgements We wish to thank the research coordinators and bedside nurses involved in the PENUT Trial as well as this study. We wish to acknowledge US taxpayers for providing the funding to support the National Institutes of Health and the PENUT study. We are indebted to the parents for their willingness to participate.
Publisher Copyright:
© 2018, Nature America, Inc., part of Springer Nature.
PY - 2018/7/1
Y1 - 2018/7/1
N2 - Objective: There is a variability regarding timing of consent and personnel used in patient recruitment for neonatal research. We explored the associations between the study personnel and timing of consent with parents’ decisional conflict and ultimately their decision to enroll. Study design: This was a multi-site, cross-sectional survey conducted between August 2015 and October 2017. Participants were parents approached to enroll their 24–28-week infant in a clinical trial. Parents completed an interviewer-administered 61-item questionnaire. Results: Overall, 163 surveys were completed; 105 by parents of enrolled infants and 58 by parents of non-enrolled infants (54.5% participation rate). Neither the individual requesting nor timing of consent was associated with parents’ knowledge score, decisional conflict, or decision to enroll. Parents preferred to be approached prenatally and by their infant’s doctor. Conclusion: Study designers and IRBs may allow flexibility in personnel and timing of consent as it is respectful of parents and may enhance trial enrollment.
AB - Objective: There is a variability regarding timing of consent and personnel used in patient recruitment for neonatal research. We explored the associations between the study personnel and timing of consent with parents’ decisional conflict and ultimately their decision to enroll. Study design: This was a multi-site, cross-sectional survey conducted between August 2015 and October 2017. Participants were parents approached to enroll their 24–28-week infant in a clinical trial. Parents completed an interviewer-administered 61-item questionnaire. Results: Overall, 163 surveys were completed; 105 by parents of enrolled infants and 58 by parents of non-enrolled infants (54.5% participation rate). Neither the individual requesting nor timing of consent was associated with parents’ knowledge score, decisional conflict, or decision to enroll. Parents preferred to be approached prenatally and by their infant’s doctor. Conclusion: Study designers and IRBs may allow flexibility in personnel and timing of consent as it is respectful of parents and may enhance trial enrollment.
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U2 - 10.1038/s41372-018-0119-6
DO - 10.1038/s41372-018-0119-6
M3 - Article
C2 - 29795451
AN - SCOPUS:85047303582
SN - 0743-8346
VL - 38
SP - 865
EP - 872
JO - Journal of Perinatology
JF - Journal of Perinatology
IS - 7
ER -